Steady-state bioequivalence study of clozapine psychotic patients in Brazil

摘要: The present work aimed to compare the relative bioavailability of Zolapin with 100 mg tablet Leponex as a reference formulation, through simple, robust and low-cost bioequivalence assays method. study design was multiple-dose, randomized, crossover patients in steady-state, performed 24 schizophrenic male patients. Subjects received twice day either or for 10 days. At days each phase, blood samples were collected at different times during 12 h after drug administration clozapine concentration determined by high performance liquid chromatography (HPLC). individual peak plasma concentrations (Cmax) area under concentration-time curve (AUC0-12h) ratios calculated. evaluated pharmacokinetic parameters quite similar both formulations. 90% confidence interval mean ratio lnCmax (0.9677 0.9937) lnAUC0-12h (0.9811 1.0029) within accepted international guidelines. results demonstrate that this methodological approach able identify bioequivalent when orally administered, terms rate extent absorption, therefore, suitable potential alternative branded antipsychotic drugs. Key words: Clozapine, bioavailability, pharmacokinetics, schizophrenia.